MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd connecta¿ 3-way stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: the three-way taps leak when used with lipid-containing medication.

Manufacturer Narrative

H.6 investigation summary: a device history record review was performed for provided lot number 9128923 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, two physical samples were provided for evaluation by our quality engineer team.Both of the samples were functionally tested for leakage; however, no signs of leakage were observed in either sample.Based on the investigation results, a manufacturing related cause could not be identified for the reported incident.At this time, further action has not been determined necessary.Our quality team will continue to monitor the production process for potential defects and emerging trends.H3 other text : see h.10.

Event Description

It has been reported that the bd connecta¿ 3-way stopcock has been found experiencing leakage during use.The following has been provided by the initial reporter: the three-way taps leak when used with lipid-containing medication.

• Brand Name: BD CONNECTA¿ 3-WAY STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9648082
• MDR Text Key: 200195013
• Report Number: 9610847-2020-00029
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 394602
• Device Lot Number: 9128923A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other